The materials used in medical devices, particularly those which are designed to be implantable or used in invasive procedures, must be carefully evaluated for safety and that evaluation documented in the premarket submission for the device. Some materials present unique risks; therefore, CDRH creates special guidance to help sponsors evaluate their devices effectively. One such draft guidance issued in April 2019 is “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol”. Nitinol’s shape memory properties have made it a useful tool in devices ranging from orthodontic archwires, cardiovascular guidewires, surgical instruments, orthopedic fracture fixation, cardiovascular stents, and transcatheter heart valves. The guidance provides recommendations on mechanical, corrosion, pitting, nickel ion release, galvanic corrosion, and biocompatibility testing, along with technical description and labeling recommendations. FDA recognized consensus standards and related guidance are cited where appropriate. The comment period for the draft guidance ended on June 19, 2019 but the submitted comments may be reviewed in the docket. If your product uses a unique material its worth your time to search for a relevant guidance (or consensus standard) on the FDA’s Device Advice web page. 

Text Copyright © 2019 Katrina Rogers